ObesityDQNCT01066806
Adequate Dairy Intake on Weight Change in Girls
A study testing counseling on increasing calcium intake and observation in people with Obesity, run by Creighton University at 1 site in United States.
Trial summary
SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low… Read more about this study
- Who is it for?
- Ages 13 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- counseling on increasing calcium intake and observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 13-14 years old (must be this age when consent is signed)
- Above the 50th percentile for BMI
- Above the 85th percentile for BMI with approval from their primary physician
- At least one and one- half years post menarche
- Habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. This will be inclusive of supplemental calcium and dietary intake.
- Willingness to increase dietary calcium (low fat [skim, 1%, 2%] milk or yogurt) for one year
Who cannot join
- Menarche prior to age 10
- History of lactose intolerance or milk allergy
- Weight >300 pounds
- BMI > 97 percentile for age and gender
- Pregnancy
- Chronic disease or disorder like diabetes, polycystic ovarian syndrome, thyroid disease, seizures or cancer (cancer is ok if it has been >10 years)
Show all 19Show fewer
- Use of steroids like prednisone, prednisolone, hydrocortisone, Flovent, Advair, or Nasonex
- Use of weight reducing medications like Meredia, alli, Dexatrim or Xenical
- Use of contraceptives like Yasmin, Ortho Tri-Cyclen, Apri, Aviane or Depo-Provera for any reason, including acne (see inclusive list)
- Use of acne medications like Accutane or high dose Vitamin A
- Use of ADHD medications like Adderall, Ritalin, Concerta. (Per Dr. Ramaswamy-Straterra OK) (see inclusive list)
- Use of seizure medications like Lamictal or Phenobarb (see inclusive list)
- Use of anti-depressants like Prozac or Effexor (see inclusive list)
- Diagnosed eating disorder
- Dieting behavior with weight loss > 10 pounds in the last 3 months (IF YES, consult with Project Manager)
- Metal in the skeleton (pins, rods, etc)
- Sibling of a child who is or has been on a dietary study in the last 5 years
- Total body BMC Z-score below -2.0 at baseline
- Participating in other ongoing research protocols
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center, Osteoporosis Research Center
Omaha, Nebraska, 68131
About this study
Official title: Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. .
HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.
- Conditions
- Obesity
- Being tested
- counseling on increasing calcium intake, observation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling on increasing calcium intakeBehavioural
The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.
observationOther
observe normal dairy intake
| Study group | Role | What they receive |
|---|---|---|
| high calcium diet | Experimental | Not described Receives: Behavioral: counseling on increasing calcium intake |
| normal calcium diet | Active comparator | Not described Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change in body fat
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJul 2008
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Joan Lappe, Creighton University
- Investigators
- Joan M Lappe, PhD, Principal investigator, Creighton University, Osteoporosis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066806
- Sponsor's protocol ID
- 07-14739
- Acronym
- DQ
- Status last verified
- Sep 2016
- First submitted
- 19 Jan 2010
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lappe JM, McMahon DJ, Laughlin A, Hanson C, Desmangles JC, Begley M, Schwartz M. The effect of increasing dairy calcium intake of adolescent girls on changes in body fat and weight. Am J Clin Nutr. 2017 May;105(5):1046-1053. doi: 10.3945/ajcn.116.138941. Epub 2017 Mar 15.
PubMed 28298396
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
- ClinicalTrials.gov ID
- NCT01066806
- Acronym / sponsor ID
- DQ / 07-14739
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. .
HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high calcium diet | Experimental | Behavioral: counseling on increasing calcium intake |
| normal calcium diet | Active comparator | Other: observation |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 13-14 years old (must be this age when consent is signed)
- Above the 50th percentile for BMI
- Above the 85th percentile for BMI with approval from their primary physician
- At least one and one- half years post menarche
- Habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. This will be inclusive of supplemental calcium and dietary intake.
Key exclusion criteria (19 listed)
- Menarche prior to age 10
- History of lactose intolerance or milk allergy
- Weight >300 pounds
- BMI > 97 percentile for age and gender
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling on increasing calcium intakeThe American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day. | Behavioural | high calcium diet |
| observationobserve normal dairy intake | Other | normal calcium diet |
Primary outcome
percent change in body fat
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Derived from this study: PubMed 28298396Lappe JM, McMahon DJ, Laughlin A, Hanson C, Desmangles JC, Begley M, Schwartz M. The effect of increasing dairy calcium intake of adolescent girls on changes in body fat and weight. Am J Clin Nutr. 2017 May;105(5):1046-1053. doi: 10.3945/ajcn.116.138941. Epub 2017 Mar 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan M Lappe, PhD principal investigator
Creighton University, Osteoporosis Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling on increasing calcium intake and observation in people with Obesity, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent change in body fat (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01066806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.